Senior Quality Engineer, Hardware – Medical Devices

ENCHANNEL MEDICAL LTD; Irvine (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

ENCHANNEL MEDICAL LTD in Irvine, California, is seeking a Quality Engineer, Staff (Hardware) to lead design controls remediation for catheter-based medical devices. This role involves ensuring compliance with regulatory standards and preparing documentation for FDA submissions. Candidates should have a Bachelor’s degree in Engineering and over 5 years of experience in the medical device industry. Strong knowledge of design controls and risk management is essential. The company fosters a diverse, inclusive work culture and offers competitive pay based on skills and experience.

Qualifications

• 5+ years of Quality Engineering experience within the medical device industry.
• Demonstrated hands-on experience with DHF restructuring.
• Direct experience supporting catheter-based medical device development.

Responsibilities

• Lead design controls remediation for catheter and hardware systems.
• Partner closely with R&D on compliant documentation.
• Support FDA and EU MDR submission readiness.

Skills

Design controls remediation

Risk management

FDA submissions

Quality system governance

Documentation management

Education

Bachelor’s degree in Engineering

Job description

ENCHANNEL MEDICAL LTD in Irvine, California, is seeking a Quality Engineer, Staff (Hardware) to lead design controls remediation for catheter-based medical devices. This role involves ensuring compliance with regulatory standards and preparing documentation for FDA submissions. Candidates should have a Bachelor’s degree in Engineering and over 5 years of experience in the medical device industry. Strong knowledge of design controls and risk management is essential. The company fosters a diverse, inclusive work culture and offers competitive pay based on skills and experience.